SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
1 kg equals how many pounds? - ANSWER-2.2 lbs
1571 = IND Application (Expanded Use) - ANSWER-Cover sheet for expanded access submissions
includes:
1. Rationale of intended use of drug.
2. Criteria for client selection.
3. Method of administration.
4. Description of facility where drug-manufactured.
5. chemistry...strength of investigational drug.
6. Pharmacology/toxicity
2 common routes for a device to go to market - ANSWER-1. Premarket notification (SIO). FDA
determines device is equivalent to device already allowed on market. Can enter market without clinical
trials.
2. Pre-market approval (PMA) - similar to NDA. FDA reviews all clinical investigations.
2.54 cm = how many inches? - ANSWER-1 Inch
A sponsor should submit a brief report to the investigator within how many days after the IND went into
effect? - ANSWER-60 days. Containing:
1. Individual study info.
2. Summary information.
3. Description of general investigational plan.
4. IB has been revised.
5. Significant protocol modifications.
SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
,SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
Additional Elements of ICF that should be provded (CFR 46) - ANSWER-1. Treatment may involve risks
which are currently unforeseeable.
2. Subject protection may be terminated by investigator.
3. Additional costs that may result from participation.
4. Consequences of withdrawing or termination.
5. New findings will be provided when they may offset willingness to participate.
6. Number of subjects involved.
Administrative Actions for Non-Compliance for IRBs - ANSWER-If FDA observes non-compliance during
inspection: May
1. withhold approval of new studies.
2. No new subjects be added to ongoing studies.
3. Terminate ongoing studies when it would not endanger subjects.
4. Notify state/federal agencies when appropriate. Parent institution is responsible for IRB
Adverse Drug Reaction (ADR) - ANSWER-All noxious and unintended responses to a medicine/product
related to any dose. Relationship between medicinal product and AE's is a reasonable possibility. (the
relationship cannot be ruled out)
Adverse Event (Definition) - ANSWER-Any untoward medical occurrence associated with the use of a
drug in humans whether or not considered drug related. It can therefore be any unfavorable and
unintended sign, symptom, or diagnosis associated with the use of a medicinal investigational product
whether or not related.
Assent (definition) - ANSWER-A child's affirmative agreement to participate in research.
Assent for Children - ANSWER-1. Permission of each child's parents must be granted. Might be one or
both. Must be documented.
SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
, SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
2. Assent should be obtained unless. Capacity of child is limited so they can't understand. Intervention of
trial is beneficial and only available through trial.
3. Or if IRB feels: No more than minimal risk. Waiver will not affect subject rights. Research couldn't
happen without assent. Additional info provided as needed.
Belmont Report: Beneficence - ANSWER-1. To secure patient well being.
2. To cover acts of kindness or charity that go beyond strict obligation.
3. Do not harm.
4. Maximize possible benefit - minimize possible harm.
Belmont Report: Justice - ANSWER-Who ought to receive the benefits of research and bear its burdens?
"fairness in distribution" or "what is deserved". Equals ought to be treated equally.
1. To each an equal share.
2. To each according to individual need.
3. to each according to individual effort.
4. to each according to societal contribution.
5. to each according to merit.
Belmont Report: Respect for persons - ANSWER-1. Individuals should be treated as autonomous agents.
An autonomous person is a capable individual of deliberation about personal goals.
2. Persons with diminished autonomy are entitled to protection (give weight to an autonomous person)
- considered opinions and choices while refraining from obstructing their actions.
BSA Calculation - ANSWER-Square root of (height in cm x weight in kg) / 3600
Can a clinical investigator submit an IDE? - ANSWER-Yes. They can sponsor their own study. They are
considered a sponsor-investigator and must comply with all responsibilities of both sponsor and
investigator.
SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
CORRECT ANSWERS 2025
1 kg equals how many pounds? - ANSWER-2.2 lbs
1571 = IND Application (Expanded Use) - ANSWER-Cover sheet for expanded access submissions
includes:
1. Rationale of intended use of drug.
2. Criteria for client selection.
3. Method of administration.
4. Description of facility where drug-manufactured.
5. chemistry...strength of investigational drug.
6. Pharmacology/toxicity
2 common routes for a device to go to market - ANSWER-1. Premarket notification (SIO). FDA
determines device is equivalent to device already allowed on market. Can enter market without clinical
trials.
2. Pre-market approval (PMA) - similar to NDA. FDA reviews all clinical investigations.
2.54 cm = how many inches? - ANSWER-1 Inch
A sponsor should submit a brief report to the investigator within how many days after the IND went into
effect? - ANSWER-60 days. Containing:
1. Individual study info.
2. Summary information.
3. Description of general investigational plan.
4. IB has been revised.
5. Significant protocol modifications.
SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
,SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
Additional Elements of ICF that should be provded (CFR 46) - ANSWER-1. Treatment may involve risks
which are currently unforeseeable.
2. Subject protection may be terminated by investigator.
3. Additional costs that may result from participation.
4. Consequences of withdrawing or termination.
5. New findings will be provided when they may offset willingness to participate.
6. Number of subjects involved.
Administrative Actions for Non-Compliance for IRBs - ANSWER-If FDA observes non-compliance during
inspection: May
1. withhold approval of new studies.
2. No new subjects be added to ongoing studies.
3. Terminate ongoing studies when it would not endanger subjects.
4. Notify state/federal agencies when appropriate. Parent institution is responsible for IRB
Adverse Drug Reaction (ADR) - ANSWER-All noxious and unintended responses to a medicine/product
related to any dose. Relationship between medicinal product and AE's is a reasonable possibility. (the
relationship cannot be ruled out)
Adverse Event (Definition) - ANSWER-Any untoward medical occurrence associated with the use of a
drug in humans whether or not considered drug related. It can therefore be any unfavorable and
unintended sign, symptom, or diagnosis associated with the use of a medicinal investigational product
whether or not related.
Assent (definition) - ANSWER-A child's affirmative agreement to participate in research.
Assent for Children - ANSWER-1. Permission of each child's parents must be granted. Might be one or
both. Must be documented.
SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
, SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
2. Assent should be obtained unless. Capacity of child is limited so they can't understand. Intervention of
trial is beneficial and only available through trial.
3. Or if IRB feels: No more than minimal risk. Waiver will not affect subject rights. Research couldn't
happen without assent. Additional info provided as needed.
Belmont Report: Beneficence - ANSWER-1. To secure patient well being.
2. To cover acts of kindness or charity that go beyond strict obligation.
3. Do not harm.
4. Maximize possible benefit - minimize possible harm.
Belmont Report: Justice - ANSWER-Who ought to receive the benefits of research and bear its burdens?
"fairness in distribution" or "what is deserved". Equals ought to be treated equally.
1. To each an equal share.
2. To each according to individual need.
3. to each according to individual effort.
4. to each according to societal contribution.
5. to each according to merit.
Belmont Report: Respect for persons - ANSWER-1. Individuals should be treated as autonomous agents.
An autonomous person is a capable individual of deliberation about personal goals.
2. Persons with diminished autonomy are entitled to protection (give weight to an autonomous person)
- considered opinions and choices while refraining from obstructing their actions.
BSA Calculation - ANSWER-Square root of (height in cm x weight in kg) / 3600
Can a clinical investigator submit an IDE? - ANSWER-Yes. They can sponsor their own study. They are
considered a sponsor-investigator and must comply with all responsibilities of both sponsor and
investigator.
SOCRA CERTIFICATION EXAM QUESTIONS WITH
CORRECT ANSWERS 2025
